functional imaging of t-cell activation with [18f]f-arag in urothelial carcinoma patients receiving neoadjuvant therapy or patients with cancer receiving standard of care anti-pd-1/l1

Conditions: Bladder Cancer

Summary: this phase ii trial studies how well fluorine f 18 ara-g positron emission tomography (pet)/magnetic resonance (mr) imaging works in measuring clinical response to atezolizumab or patients with cancer receiving standard of care anti-pd-1/l1. diagnostic procedures, such as fluorine f 18 ara-g pet/mr imaging, may help measure a patient's response to standard of care atezolizumab or anti-pd-1/l1 treatment.

primary objectives: i. to assess the change in fluorine f 18 ara-g (\[18f\]f-arag) uptake in primary and/or metastatic tumor(s) on whole-body \[18f\]f-arag pet/mr imaging associated with neoadjuvant atezolizumab and standard of care (soc) anti-pd-1 or anti-pd-l1 treatment. secondary objectives: i. to correlate change in \[18f\]f-arag uptake within the primary tumor with clinical and pathologic response in patients treated with neoadjuvant atezolizumab. (cohort 1) ii. to assess \[18f\]f-arag uptake in lymphoid organs before and after anti-pd-1 or anti-pd-l1 treatment. (cohort 1 and 2) outline: patients are assigned to 1 or 2 cohorts. cohort i (neoadjuvant cohort): patients receive fluorine f 18 ara-g intravenously (iv) and undergo pet/mr imaging over 1.5-3 hours within 7 days of starting standard of care atezolizumab and within 7 days before surgery. cohort ii (soc cohort): patients receive fluorine f 18 ara-g iv and undergo pet/mr imaging over 1.5-3 hours within 7 days of initiating course 1 of anti-pd-1 or anti-pd-l1 therapy and between day 15 of course 1 and day 7 of course 2 of anti-pd-1 or anti-pd-l1 treatment. after completion of study, patients are followed up at days 2 and 8.

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented cancer to which anti-pd1 or anti-pdl1 are approved therapies * eligible for with plan to undergo neoadjuvant treatment with atezolizumab followed by surgery as part of a companion study (nct02451423), or planned to undergo treatment with anti-pd-1 or anti-pd-l1 per standard of care * must have measurable disease by response evaluation criteria in solid tumors (recist) version (v)1.1 regardless of disease stage (e.g. localized, locally advanced, or metastatic) * in female patients, negative pregnancy test with no plans to become pregnant during the duration of the study * able to provide informed consent and follow the study guidelines * archival tumor tissue from biopsy or resection will be required for all patients; archival tissue should be of good quality based on total and viable tumor contents; fine needle aspiration, brushing, and cytologic cell pellets are not acceptable exclusion criteria: * history of prior treatment with immune checkpoint antibodies (e.g. anti-pd1, anti-pdl1, anti-ctla4 antibody) or co-stimulatory agonist antibodies (e.g. anti-41bb, anti-ox40) \* prior intravesical treatment with bacillus calmette-guerin (bcg) is allowed; however, the last dose must be at least 6 weeks from time of enrollment and patients must have documented progressive disease at least 6 weeks from completion of last bcg * diagnosis of immunodeficiency including history of human immunodeficiency virus (hiv) * receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to first injection of \[18f\]f-arag \* topical and inhaled corticosteroids are allowed * prior allogeneic stem cell or solid organ transplant * known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study * biopsy or resection of the primary tumor within 14 days the first injection of \[18f\]f-arag * contraindication to magnetic resonance (mri) imaging, as determined through review of the university of california, san francisco (ucsf) mri screening form by study investigator * evidence of active infection within 14 days of study enrollment * female patients who are pregnant or breastfeeding * inability to receive furosemide (lasix) in the opinion of the treating investigator * patients that plan to receive off-label use of anti-pd1 or anti-pdl1